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Switching Medication to Treat Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00044655
Recruitment Status : Completed
First Posted : September 5, 2002
Results First Posted : December 5, 2013
Last Update Posted : April 28, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE September 3, 2002
First Posted Date  ICMJE September 5, 2002
Results First Submitted Date  ICMJE September 27, 2013
Results First Posted Date  ICMJE December 5, 2013
Last Update Posted Date April 28, 2016
Study Start Date  ICMJE July 2001
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2016)
Number Who Discontinued Medication Within First 6 Study Months [ Time Frame: Measured at Six Months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
Psychiatric Symptoms, Hospitalization, and Medication Side Effects [ Time Frame: Measured at Year 1 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Switching Medication to Treat Schizophrenia
Official Title  ICMJE Effectiveness of Switching Antipsychotic Medications
Brief Summary This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.
Detailed Description

Over the past several years, new, "atypical" antipsychotic medications have become available to treat schizophrenia with little information to guide prescribing for relatively stable outpatients.

Participants will be randomly assigned to either continue taking their current medications for schizophrenia, or to switch to a new medication. Participants assigned to switch to a new medication will begin receiving either olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), quetiapine (Seroquel), or aripiprazole (Abilify), depending on what they are currently taking. Participants currently taking a single oral medication will switch to olanzapine, risperidone, ziprasidone, quetiapine, or aripiprazole. Participants currently taking a single conventional injectable will begin taking long-acting injectable risperidone (Risperdal Consta). Participants currently taking two antipsychotic medications will begin taking only one of the medications they are currently using. Participants will stay on their assigned treatment for 6 months, after which time the participant's prescribing psychiatrist will advise the participant on which medication should be used. Study participants are interviewed at study start and at follow-up visits for 1 year.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Risperidone
    As prescribed by routine prescriber (not dictated by study protocol)
    Other Name: Risperdal, Risperdal Consta
  • Drug: Olanzapine
    As prescribed by routine prescriber (not dictated by study protocol)
    Other Name: Zyprexa
  • Drug: Ziprasidone
    As prescribed by routine prescriber (not dictated by study protocol)
    Other Name: Geodon
  • Drug: Quetiapine
    As prescribed by routine prescriber (not dictated by study protocol)
    Other Name: Seroquel
  • Drug: Aripiprazole
    As prescribed by routine prescriber (not dictated by study protocol)
    Other Name: Abilify
Study Arms  ICMJE
  • Active Comparator: Stay on baseline medication prescribed
    Participants will continue taking medication prescribed at study entry: 1) either long-acting injectable haloperidol or fluphenazine, OR 2) two antipsychotic medications which might include a combination of any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications.
    Interventions:
    • Drug: Risperidone
    • Drug: Olanzapine
    • Drug: Ziprasidone
    • Drug: Quetiapine
    • Drug: Aripiprazole
  • Active Comparator: Switch per study protocol
    Participants will change medications from medication prescribed at study entry, either: 1) long-acting injectable risperidone, OR 2) one of the two antipsychotic medications prescribed at baseline which may include any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications.
    Interventions:
    • Drug: Risperidone
    • Drug: Olanzapine
    • Drug: Ziprasidone
    • Drug: Quetiapine
    • Drug: Aripiprazole
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2016)
219
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
300
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • SCID diagnosis of schizophrenia or schizoaffective disorder
  • Partially remitted outpatients, defined as persons who have received clear symptomatic benefit from antipsychotic medication but remain symptomatic (due to lack of efficacy or inability to tolerate an efficacious dose) or suffer significant side effects
  • Treatment with antipsychotic medications for at least 2 months
  • Received at least 1 outpatient mental health service every 3 months for the past 6 months

Exclusion criteria:

  • Severe symptoms or side effects that indicate the necessity for a medication change
  • Currently taking 3 or more antipsychotic medications for ongoing daily administration (PRN medications and mood stabilizers are allowable)
  • Treatment with clozapine
  • One or more nights spent in a psychiatric hospitalization within the past 3 months
  • Received services from a crisis intervention program within the past 3 months
  • Require placement in a skilled nursing facility as a result of a physical condition or disability
  • Criminal charges pending (once charges clear, the person will be considered)
  • Pregnant or breast feeding
  • Contraindication to any of the medications to which the patient might be assigned
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00044655
Other Study ID Numbers  ICMJE GCO 98-924
R01MH059312 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Study Chair: Susan M. Essock, PhD Columbia University
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP